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New MedTech Strategy in development

The Department of Health and Social Care is working on a new MedTech Strategy. The Diagnostics Strategy was presented to members at the Annual General Meeting in March, and the Medtech Strategy to the MedTech Trade Association forum in April. The aim of these strategies is to ensure the healthcare system has access to safe, effective, innovative and ground-breaking medical…
Ben Kemp
April 14, 2022
Membership NewsMembership News Archive

Delay to UKCA consultation response

The UK Government has entered into their pre-election period, which means that they are limited on what can and cannot be discussed in relation to policy. Because of this, MHRA have confirmed that there will be a delay to publishing the response to the MHRA UKCA consultation (which closed in November), until this period is over on 9 May. The…
Ben Kemp
April 14, 2022
Membership NewsMembership News Archive

Infectious Disease Working Party

BIVDA has had an AMR working party since about 2016, but this has largely been focussed on having speakers to inform the group and ensuring the messaging about the role of IVDs is there for all the DHSC and NHS policy work. During the pandemic we also initiated a taskforce to help with anything COVID related and to ensure information…
Ben Kemp
April 14, 2022
Membership NewsMembership News Archive

New paper highlights overlap in EU and US requirements to support efficient compliance

Members may find this white paper useful in ascertaining EU IVDR clinical evidence requirements and how manufacturers can efficiently comply. It is imperative that manufacturers do not underestimate the time required to source the right clinical evidence for their products. As the risk to individual and public health increases with each device classification under the IVDR, the corresponding conformity assessment…
Ben Kemp
April 8, 2022
Membership NewsMembership News Archive

NHS England updated the Trade Association forum with regards to their Evergreen programme

From April 2022, the first Sustainability Supplier Roadmap Milestone was reached with the adoption of PPN 06/20, which is taking Account of Social Value in the Award of Central government Contracts. As a reminder, PPN 06/20 will be included in all tenders from 1st April 2022, with all contracts requiring a climate change question within the 10% minimum weighting criteria.…
Ben Kemp
April 8, 2022
Membership NewsMembership News Archive

IVDeology hosting training session on IVD Regulation

IVDeology are providing a full day training session on an introduction to IVD regulation in Europe and the UK. The agenda covers the framework of the IVD Regulation in Europe, quality management system requirements to meet this legislation, UKCA marking requirements according to the latest information, and the chance to discuss your own specific enquiries in the Q&A session. The…
Ben Kemp
April 8, 2022
Membership NewsMembership News Archive

BIVDA member company QuantuMDx wins two Bionow Awards 2021

Congratulations to BIVDA member company QuantuMDx on their winning two Bionow Awards 2021 at the ceremony held on Thursday night. The company was shortlisted for three awards, winning two in total: Project of the Year (for their efficient manufacturing of the Q-POC™ product range, and Promising Technologist of the Year (Molly Jowsey, Senior Mechanical Engineer). BIVDA congratulates the team on…
admin
April 1, 2022
Membership NewsMembership News Archive

BIVDA meets with Genomics England, NHS England and the Office for Life Sciences to discuss future engagement on genomics

This week Doris-Ann and the Chair of the Genomics Working Party, Dr Philip Beer, had a meeting with the Chief Executive of Genomics England (GEL), Chris Wigley, the deputy director for Genomics at NHS E&I, Alexandra Pickard and the head of Innovation & Growth at the OLS, Colin Wilson. This as following the recent meeting with the working party to…
admin
April 1, 2022
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